| CTRI Number |
CTRI/2017/12/010901 [Registered on: 18/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of wet cupping in comparison to Diclofenac gel in patients with knee osteoarthritis |
|
Scientific Title of Study
|
Therapeutic Evaluation of Hijamat-bish-Shart (Wet Cupping) in the treatment of Knee Osteoarthritis. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheikh Haneef Mohammad |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
New Delhi
DELHI
110062
India |
| Phone |
9811545161 |
| Fax |
9811545161 |
| Email |
jshm8272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azhar Jabeen |
| Designation |
Asst Professor |
| Affiliation |
jamia hamdard |
| Address |
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
Anne Marie PG Girls Hostel, Jamia Hamdard,
Handard Nagar
New Delhi
DELHI
110062
India |
| Phone |
9899315252 |
| Fax |
|
| Email |
jabeendr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fasihuzaman |
| Designation |
Associate Professor |
| Affiliation |
jamia hamdard |
| Address |
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
South
DELHI
110062
India |
| Phone |
9911256786 |
| Fax |
9911256786 |
| Email |
drfasihuzzaman@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard university,Hamdard Nagar, New Delhi, 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Moalijat,
Faculty of Medicine Unani,
Jamia Hamdard,
New Delhi,
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sheikh Haneef Mohmad |
Majeedia Unani Hoapital, Jamia Hamdard, new Delhi |
Room No. 06, Moalijat OPD, Majeedia Unani hoapital,jamia Hamdard, Hamdard Nagar, New Delhi, 110062
South
DELHI |
9811545161
shm8272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee for clinical trials in Unani Drugs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, knee osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac |
Diclofenac gel
control group received the topical Diclofenac gel up to 28 days. |
| Intervention |
wet cupping (Hijamah)therapy |
wet cupping therapy.
seven sessions of cupping in 6 weeks at weekly interval |
|
|
Inclusion Criteria
|
| Age From |
38.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed according to American College of Rheumatology Criteria for Osteoarthritis.
2. Patients with symptoms consistent with OA of knee for at least six months prior to screening.
3. Patients who discontinued all NSAIDS or other analgesic medication taken for any other condition, including their knee pain.
4. Patients signed the informed consent and follow the protocol voluntarily |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation
2. Anemia
3. Uncontrolled Diabetes Mellitus
4. Patients taking anticoagulants
5. Patients with a past history of blood disorders
6. Patients participated in an experimental device, study or any clinical trial
within the previous 30 days prior to screening
7. Any knee surgery in the previous three months
8. Other types of arthritis
9. Patients with any inter current disease(s) or condition(s) that may interfere
with the completion of six week follow up—neurological problems, severe
congenital defects, peptic ulcer, severe liver disease, severe coronary disease,
hypertension, renal disease, abnormal mental state, or other clinically
significant conditions
10. Patients on steroid therapy or NSAIDS.
11. Patients unable to understand WOMAC questionnaire form.
12. Patients allergic to topical diclofenac gel and with a history of gastritis. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index.
Active range of motion.
Radiological assessment (Kellgren-Lawrence Radiographic Grading Scale of Osteoarthritis of the Tibiofemoral Joint, all Grades)
Visual analogue scale (VAS) |
The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide safe alternative and economical treatment for knee osteoarthritis |
To provide safe alternative and economical treatment for knee osteoarthritis |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/11/2011 |
| Date of Study Completion (India) |
28/09/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
review articles published but results not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is a major cause of disability in both the developed and developing world. With the population aging, the prevalence of osteoarthritis is increasing and its consequences are impacting significantly on society. (Brooks, M, & Lund, 2002) Although the etiology of osteoarthritis is incompletely understood, the accompanying biochemical, structural, and metabolic changes in joint cartilage have been well documented. Pain and functional limitation are the primary clinical manifestations of osteoarthritis of the knee. Current recommendations for managing osteoarthritis, including guidelines published by the American College of Rheumatology and European League of Associations of Rheumatology, focus on relieving pain and stiffness and maintaining or improving physical function as important goals of therapy. Pharmacologic management of osteoarthritis is often ineffective, and agents such as NSAIDs may cause unwanted and dangerous side effects. Various modalities of alternative and complementary medicine are commonly used worldwide as an alternative to conventional therapy. Unani system of medicine can be the best alternative as it is rich therapy not only in the terms of pharmacological agents but also numerous modes of non-pharmacological means i.e., Regimenal therapy, with least or no known side effects. Keeping in view above facts, present study was designed and conducted to evaluate the efficacy of Hijamah (cupping) in the treatment of knee osteoarthritis and provide a safe and economical alternative. The study was conducted in the Majeedia Hospital and department of Ilaj-bit-Tadbeer (Regimenal therapy) of faculty of medicine, Jamia Hamdard, New Delhi. The study was randomized controlled trial with a sample size of 57. All the patients were enrolled with prior screening as per the guidelines of protocol. Almost all the patients were having bilateral knee osteoarthritis. Good Clinical Practice (GCP) guidelines were followed during the whole study. The duration of the study was 1 year and the duration of the protocol therapy was 6 weeks.
Patients were randomly allocated into the test and control group. The patients in the test group were subjected to Hijamat-bish-Shart (wet cupping) on weekly basis while the patients in the control group were given Diclofenac gel for the local application to be used twice daily for the 28 days. The assessment of efficacy in the study was done with the outcome measures WOMAC Osteoarthritis Index LK3.1 (IK), visual analogue scale of pain (VAS) and active range of motion (AROM) that were recorded at the baseline, on the 28th day and at the end of treatment, i.e., 42nd day.
To assess the safety of the intervention, hematological (hemogram with ESR) and biochemical parameters, including liver function test and kidney function test (KFT) were carried out pre and post intervention. The data was recorded and subjected to statistical analysis after the completion of study.
|